Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

Completed · Phase 3 · Has a placebo group

Conditions studied: ASCVD, Elevated Cholesterol

In brief

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.

Key facts

Study ID

NCT03399370

Run by

The Medicines Company

People needed

1561

Starts

2017-12-21

Expected to finish

2019-09-17

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants ≥18 years of age.
• History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).
• Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
• Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
• Participants on statins should be receiving a maximally tolerated dose.
• Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
• Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.

You may not qualify if…

• New York Heart Association (NYHA) class IV heart failure.
• Uncontrolled cardiac arrhythmia
• Uncontrolled severe hypertension
• Active liver disease
• Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
• Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
• Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
• Women who are surgically sterilized at least 3 months prior to enrollment.
• Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
• Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
• Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Research Site 10001-138 — Foley, Alabama, United States
• Research Site 10001-113 — Huntsville, Alabama, United States
• Research Site 10001-058 — Mobile, Alabama, United States
• Research Site 10001-037 — Montgomery, Alabama, United States
• Research Site 10001-076 — Saraland, Alabama, United States
• Research Site 10001-013 — Chandler, Arizona, United States
• Research Site 10001-077 — Mesa, Arizona, United States
• Research Site 10001-136 — Phoenix, Arizona, United States
• Research Site 10001-051 — Surprise, Arizona, United States
• Research Site 10001-019 — Tucson, Arizona, United States
• Research Site 10001-004 — Tucson, Arizona, United States
• Research Site 10001-132 — Tucson, Arizona, United States
• Research Site 10001-073 — Beverly Hills, California, United States
• Research Site 10001-050 — Canoga Park, California, United States
• Research Site 10001-011 — Carlsbad, California, United States
• Research Site 10001-065 — El Cajon, California, United States
• Research Site 10001-150 — Los Angeles, California, United States
• Research Site 10001-043 — Northridge, California, United States
• Research Site 10001-022 — Northridge, California, United States
• Research Site 10001-033 — Sacramento, California, United States
• Research Site 10001-105 — San Ramon, California, United States
• Research Site 10001-008 — Santa Rosa, California, United States
• Research Site 10001-153 — Spring Valley, California, United States
• Research Site 10001-044 — Torrance, California, United States
• Research Site 10001-015 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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